Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections
21 luglio 2017 aggiornato da: LIjuan Zhou, People's Hospital of Zhengzhou University
A Retrospective Study of Relationships Between Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections Treated With Teicoplanin
This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
- Patients and protocol This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016. Patients were included who met the following criteria: (1) age≥18 years, (2) duration of teicoplanin therapy≥5 days, (3) written informed consent was obtained from each patients. Patients were excluded who fulfilled any of the following criteria: (1) Patients who were allergy to teicoplanin, (2) pregnant women, (3) patients with hematopoietic function, (4) patients unable to evaluate efficacy and safety. This study was approved by the research ethics committee of the Zhengzhou Central Hospital affiliated to Zhengzhou University.
- Treatment regimen and groups According to CLcr and teicoplanin loading dose regimen, all patients were divided into four groups. Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d. Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d. Group C (CLcr<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d. Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d. The maintenance dosing was adjusted by Cmin and CLcr in all groups. The target Cmin was set to 15~30 mg/L. If Cmin<15 mg/L or >30 mg/L, the maintenance dosage was increased or decreased appropriately up to target Cmin range. CLcr values for male and female were calculated based on the following equations, respectively.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
113
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
The clinical data of 113 patients who were suffered with severe Gram-positive infection and treated with teicoplanin from February 2015 to August 2016 were retrospectively analyzed.
Descrizione
Inclusion Criteria:
- age≥18 years
- duration of teicoplanin therapy≥5 days
- written informed consent was obtained from each patients
Exclusion Criteria:
- Patients who were allergy to teicoplanin
- pregnant women
- patients with hematopoietic function
- patients unable to evaluate efficacy and safety
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Group A
Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
|
Group B
Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
|
Group C
Group C (CLcr<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
|
Group D
Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Serum teicoplanin trough concentrations
Lasso di tempo: 0.5 hour before teicoplanin administration on the fourth day
|
Teicoplanin trough samples were taken immediately 30 minutes before teicoplanin administration on the fourth day.
Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min.
Serum teicoplanin trough concentrations (Cmin) were determined by a high-performance liquid chromatography method as previously described.
The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.
|
0.5 hour before teicoplanin administration on the fourth day
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
White blood cell count (WBC)
Lasso di tempo: 2 years
|
It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
C-reaction protein (CRP)
Lasso di tempo: 2 years
|
It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
Asparttate aminotransferase (AST)
Lasso di tempo: 2 years
|
It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
Alanine aminotransferase (ALT)
Lasso di tempo: 2 years
|
It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
Serum creatinine (Scr)
Lasso di tempo: 2 years
|
It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
CLcr
Lasso di tempo: 2 years
|
It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2015
Completamento primario (Effettivo)
20 agosto 2016
Completamento dello studio (Effettivo)
30 ottobre 2016
Date di iscrizione allo studio
Primo inviato
19 luglio 2017
Primo inviato che soddisfa i criteri di controllo qualità
21 luglio 2017
Primo Inserito (Effettivo)
25 luglio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 luglio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 luglio 2017
Ultimo verificato
1 luglio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LZhou
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
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